Events

KimVent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Halyard Health, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    71110
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1678-2015
  • 사례 시작날짜
    2015-04-14
  • 사례 출판 날짜
    2015-05-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136144
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheters, suction, tracheobronchial - Product Code BSY
  • 원인
    The internal blue flapper valve of certain kimvent turbo-cleaning closed suction system for adults may have a potential defect. if present, the defect potentially allows air to leak out of the closed ventilator circuit.
  • 조치
    Halyard Health Regulatory Affairs sent an Urgent Voluntary Product Recall letter dated April 16, 2015, to all affected consignees. Consignees were instructed to quarantine and discontinue use of the recalled product. Specific return instructions were provided in the Notice. The consignees were also requested to provide a response to to the recall notification. Wholesalers were instructed to follow their internal recall procedures to identify and address affected products. Consignees with questions were instructed to call Halyard Health Regulatory Affairs at 470-448-5700.

Device

KimVent
  • 모델명 / 제조번호(시리얼번호)
    M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.
  • 제품 설명
    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
  • Manufacturer
    Halyard Health, Inc

Manufacturer

Halyard Health, Inc
  • 제조사 주소
    Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
  • Source
    USFDA